Study of CO2 fractional laser treatment for GSM

JRCT ID: jRCTs032210633

Registered date:28/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Genitourinary Syndrome of Menopause
• Date of first enrollment: 28/02/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The content of the intervention is to use a laser probe with a 360 deg attachment.
The laser program is the same
intravaginally irradiate the target patient with CO2 laser 3 times a month
Irradiation energy setting
Output: 30W or 40W
Duell time: 1000 microsecond
Spacing: 1000 micrometer
Smart stack: 1-3

Outcome(s)

• Primary Outcome: NRS scores for pain investigated immediately after the first treatment

Secondary Outcome

Efficacy: Vaginal epithelial maturity (cytodiagnosis), vaginal environment (vaginal pH), patient QOL questionnaire survey score
Usefulness: NRS scores for pain investigated immediately after the second treatment, Number of cases by probe selected by the study subject at the time of the third treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patients aged 20 years or older with a diagnosis of GSM
2) Patients who wish to receive CO2 fractional laser treatment
3) Patients have given written consent to participate in this study.

Exclude criteria

1) Patients with dysplastic lesions of the cervix, vagina, and vulva
2) Patients with active pelvic infections
3) Unexplained genital bleeding
4) Patients with vaginal and / or cervical wounds
5) Patients with advanced malignant tumors and severe co-morbidities
6) Patients who have already received CO2 fractional laser treatment for GSM
7) Patients judged by the investigator to be inappropriate

Related Information

• Primary Sponsor: Suzuki Nao
• Source(s) of Monetary Support: DKSH Market Expansion Services Japan K.K.